Malnutrition, Oncology
Conditions
Keywords
Oral nutritional supplement, Oncology, Omega 3
Brief summary
A single arm intervention study examining the effect of an omega 3 enriched oral nutritional supplement on nutritional status of CRC and NSCLC patients
Interventions
DIETARY_SUPPLEMENTOral Nutritional Supplement
twice daily serving of the study product
Sponsors
Nutricia Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically proven CRC or histologically or cytologically proven NSCLC 2. Eligible and scheduled for at least 2 cycles of 4-week cycles of systemic treatment, 3 cycles of 3-week cycles of systemic treatment or 4 cycles of 2-week cycles of systemic treatment 3. At risk of malnutrition or malnourished \[PG-SGA-SF \> 4\] 4. Performance status ECOG 0 or 1 5. Weight loss grade 0-3 according to Martin et al1 6. \<11% weight loss in the past 6 months 7. Age ≥ 18 years 8. Written informed consent
Exclusion criteria
1. Presence of ileostoma or ileal pouch 2. GI-related or major surgery in 30 days prior to baseline 3. Severe hypercalcemia, i.e. total calcium level, corrected for albumin ≥ 14.0 mg/dL (3.5 mmol/L) 4. Use of ONS, enteral nutrition or parenteral nutrition within 14 days prior to entry into the study 5. Use of fish oil containing supplements, within 30 days prior to entry into the study or expected to use this during the study 6. Use of more than 200 iU/day of vitamin D containing supplements within 30 days prior to entry into the study or expected to use this during the study 7. Life expectancy of \< 3 months 8. Severe renal dysfunction (\<29 ml/min/1.73m2 eGRF or albumin:creatinine (ACR) \> 30) or hepatic encephalopathy 9. Allergy to cow's milk protein or fish, known protein sensitivity or suffering galactosemia 10. Known pregnancy or lactation 11. Current alcohol or drug abuse in opinion of the investigator 12. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements 13. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in EPA concentration in the phospholipid fraction of the erythrocyte membrane [% of total fatty acids] | at end of first in-study treatment cycle compared to baseline |
Secondary
| Measure | Time frame |
|---|---|
| Change in protein intake [g/kg bw/day] [key secondary outcome) | at end of first in-study treatment cycle compared to baseline |
| Change in energy intake [kcal/day] | at end of first in-study treatment cycle compared to baseline |
| Change in protein intake [g/day] [key secondary outcome) | at end of first in-study treatment cycle compared to baseline |
| Provided vitamin D supplementation [µg/day] by the test product | Throughout total intervention period - about 2 months |
| Change in fatty acid profile in the phospholipid fraction of the cell membrane of erythrocytes [% of total fatty acids] | at end of first in-study treatment cycle compared to baseline |
| Change in energy intake [kcal/kg bw/day] | at end of first in-study treatment cycle compared to baseline |
Countries
Belgium, Czechia, Ireland
Outcome results
None listed